Project Associate, Research

仕事内容

Responsibilities:

• Has general understanding of regulatory documents, the electronic common technical document (eCTD) specifications.

• Experience with electronic document management systems, and capable of supporting the lifecycle of regulatory documents, from creation to review and completion.

• Embraces technology, and have advanced working knowledge of Microsoft Word

• Able to format documents in MS Word.

• Understands and adheres to standards and processes, willing and able to do minute and repetitive tasks on the computer.

• Collaborates cross-functionally (Research, Regulatory Affairs, Regulatory Operations, Medical Writing/Content Managers, Clinical Development) to support timely availability of regulatory documents.

• Is able to work in ambiguous situations, sometimes without known precedence, and able to think critically to implement effective solutions.

• Able to manage multiple tasks simultaneously with strong attention to detail and work with tight deadlines, but flexible enough to pivot when necessary.

• Participates in process improvements, new standards, updating systems, and other activities related to continuous improvement in support of submissions.

• Is able to work onsite at least 3 days a week.

Basic Qualifications:

High School and Six Years’ Experience

OR

Associate Degree and Five Years’ Experience

OR

Bachelor's Degree and Four Years’ Experience

OR

Masters' Degree and Two Years’ Experience

Preferred Qualifications:

• Bachelor’s degree with regulatory submission experience preferred. High school diploma with relevant experience acceptable.

• Attention to detail, patient, organized and thorough.

• Looks for efficiency in processes.

• Self-motivated, willingness to learn and take direction, and has high work ethic.

• Clear and effective communication, able to influence without authority and work in a matrixed environment.

• Operates in a professional, service-oriented manner.

• Resourceful self-starter with problem-solving and critical thinking skills.

• Understands general principles of project management, timelines and interdependencies of deliverables.

• Ability to work collaboratively; experience communicating with stakeholders at all levels is desirable.

• Strong proficiency in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, and Teams), Adobe Acrobat, Veeva systems and Smartsheet.

People Leader Accountabilities

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations, and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.